Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE4
38 participants
INTERVENTIONAL
2015-01-22
2023-05-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
There are three potential mechanisms by which DMEK may provide better visual acuity outcomes than DSAEK; graft thickness, interface haze and corneal higher-order aberrations. Graft thickness has been correlated with best spectacle corrected visual acuity (BSCVA) outcomes among thinner grafts. One retrospective case series found that 71% of thin endothelial grafts (defined as \<131μm) had BSCVA of 20/25 or better while only 50% of thick grafts (defined as ≥131) achieved this. In addition, higher-order aberrations, in particular of the posterior cornea, are increased after DSAEK. Theoretically, given the decreased tissue transplanted after DMEK this would be lessened, however, one retrospective series looking at higher order aberrations in DMEK compared with DSAEK found no difference in posterior aberrations of the central 4.0 mm zone between the two groups. Finally, interface haze may be increased in DSAEK and has been correlated with BSCVA.
Ultrathin DSAEK involves donor preparation with a deep microkeratome pass to produce donor grafts less than 100 um thick. This procedure may have similar results to DMEK but without the technical difficulties. Several large prospective series show similar visual outcome results and rates of immunologic rejection between ultrathin DSAEK and DMEK, however comparisons are difficult. This comparative effectiveness clinical trial could directly address these important issues. The investigators also anticipate that secondary analyses of the trial data will allow us to address several more.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
DSAEK
Type of corneal transplant; Tissue grafts will be cut to the right thickness using a microkeratome prepared at the eye bank per standard eye bank protocol (about 60-90 microns thick). A 4 mm corneal incision will be used, with Endoserter as the means of inserting the graft, an FDA approved device for this purpose.
DSAEK
Endoserter
The Endoserter, a corneal endothelium device, is an approved FDA device. This will be used to insert and position the graft into the anterior chamber during endothelial replacement surgery. It is a sterile, single-use instrument.
Prednisolone
Prednisolone is a corticosteroid used to alleviate swelling post-surgery.
Ofloxacin
Ofloxacin is an antibiotic used to treat bacterial infections of the eye.
Tropicamide
Tropicamide is a prescription drug used to dilate pupils during an eye exam.
Phenylephrine
Phenylephrine is a prescription drug used to dilate pupils during an eye exam.
DMEK
Type of corneal transplant; Endothelial grafts will be pre-peeled at the eyebank (70%). In the operating room the remaining 30% will be peeled, and the endothelium will be stained with trypan blue. A 3.5 mm corneal incision will be used and the graft will be inserted with a modified jones tube injector. The tap technique will be used to position the graft.
DMEK
Prednisolone
Prednisolone is a corticosteroid used to alleviate swelling post-surgery.
Ofloxacin
Ofloxacin is an antibiotic used to treat bacterial infections of the eye.
Tropicamide
Tropicamide is a prescription drug used to dilate pupils during an eye exam.
Phenylephrine
Phenylephrine is a prescription drug used to dilate pupils during an eye exam.
Jones Tube
The Jones Tube will be used to insert the graft into a 3.5 mm corneal incision during endothelial replacement surgery.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
DSAEK
DMEK
Endoserter
The Endoserter, a corneal endothelium device, is an approved FDA device. This will be used to insert and position the graft into the anterior chamber during endothelial replacement surgery. It is a sterile, single-use instrument.
Prednisolone
Prednisolone is a corticosteroid used to alleviate swelling post-surgery.
Ofloxacin
Ofloxacin is an antibiotic used to treat bacterial infections of the eye.
Tropicamide
Tropicamide is a prescription drug used to dilate pupils during an eye exam.
Phenylephrine
Phenylephrine is a prescription drug used to dilate pupils during an eye exam.
Jones Tube
The Jones Tube will be used to insert the graft into a 3.5 mm corneal incision during endothelial replacement surgery.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Good candidates for corneal transplantation for either DMEK or DSAEK
* Willingness and ability to undergo a cornea transplantation
* Willingness to participate in follow-up visits
Exclusion Criteria
* Participants who are not suitable for the DMEK or DSAEK surgeries
* Prior Endothelial Keratoplasty (EK) or any other ophthalmic surgery except uncomplicated cataract surgery
* Indication for surgery that is not suitable for EK (e.g. keratoconus, stromal dystrophies and scars)
* Presence of a condition that increases the probability for failure (e.g., heavily vascularized cornea, uncontrolled uveitis)
* Other primary endothelial dysfunction conditions including posterior polymorphous corneal dystrophy and congenital hereditary corneal dystrophy
* Aphakia, or anterior chamber intraocular lens (IOL) in study eye prior to or anticipated during EK
* Planned intraocular lens exchange of an anterior chamber IOL with a posterior chamber IOL in study at time of study EK
* Pre-operative central sub-epithelial or stromal scarring that the investigator believes is visually significant and could impact post-operative stromal clarity assessment
* Peripheral anterior synechiae (iris to angle) in the angle greater than a total of three clock hours
* Hypotony (Intraocular pressure \<10mmHg)
* Uncontrolled (defined as intraocular pressure \>25mmHg) glaucoma Visually significant optic nerve or macular pathology
* Visually significant optic nerve or macular pathology
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of California, San Francisco
OTHER
Stanford University
OTHER
Oregon Health and Science University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Winston Chamberlain, MD, PhD
Ophthalmologist
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Winston Chamberlain, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Oregon Health and Science University
Jennifer Rose-Nussbaumer, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Charles Lin, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Byers Eye Institute, Stanford University
Palo Alto, California, United States
F. I. Proctor Foundation, University of California, San Francisco
San Francisco, California, United States
Casey Eye Institute, Oregon Health & Science University
Portland, Oregon, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Price FW Jr, Price MO. Evolution of endothelial keratoplasty. Cornea. 2013 Nov;32 Suppl 1:S28-32. doi: 10.1097/ICO.0b013e3182a0a307.
Chen ES, Terry MA, Shamie N, Hoar KL, Friend DJ. Descemet-stripping automated endothelial keratoplasty: six-month results in a prospective study of 100 eyes. Cornea. 2008 Jun;27(5):514-20. doi: 10.1097/ICO.0b013e3181611c50.
Ham L, Dapena I, van Luijk C, van der Wees J, Melles GR. Descemet membrane endothelial keratoplasty (DMEK) for Fuchs endothelial dystrophy: review of the first 50 consecutive cases. Eye (Lond). 2009 Oct;23(10):1990-8. doi: 10.1038/eye.2008.393. Epub 2009 Jan 30.
Dirisamer M, van Dijk K, Dapena I, Ham L, Oganes O, Frank LE, Melles GR. Prevention and management of graft detachment in descemet membrane endothelial keratoplasty. Arch Ophthalmol. 2012 Mar;130(3):280-91. doi: 10.1001/archophthalmol.2011.343. Epub 2011 Nov 14.
Kruse FE, Laaser K, Cursiefen C, Heindl LM, Schlotzer-Schrehardt U, Riss S, Bachmann BO. A stepwise approach to donor preparation and insertion increases safety and outcome of Descemet membrane endothelial keratoplasty. Cornea. 2011 May;30(5):580-7. doi: 10.1097/ico.0b013e3182000e2e.
Rudolph M, Laaser K, Bachmann BO, Cursiefen C, Epstein D, Kruse FE. Corneal higher-order aberrations after Descemet's membrane endothelial keratoplasty. Ophthalmology. 2012 Mar;119(3):528-35. doi: 10.1016/j.ophtha.2011.08.034. Epub 2011 Dec 22.
Busin M, Madi S, Santorum P, Scorcia V, Beltz J. Ultrathin descemet's stripping automated endothelial keratoplasty with the microkeratome double-pass technique: two-year outcomes. Ophthalmology. 2013 Jun;120(6):1186-94. doi: 10.1016/j.ophtha.2012.11.030. Epub 2013 Mar 1.
Guerra FP, Anshu A, Price MO, Giebel AW, Price FW. Descemet's membrane endothelial keratoplasty: prospective study of 1-year visual outcomes, graft survival, and endothelial cell loss. Ophthalmology. 2011 Dec;118(12):2368-73. doi: 10.1016/j.ophtha.2011.06.002. Epub 2011 Aug 27.
Ang MJ, Chamberlain W, Lin CC, Pickel J, Austin A, Rose-Nussbaumer J. Effect of Unilateral Endothelial Keratoplasty on Vision-Related Quality-of-Life Outcomes in the Descemet Endothelial Thickness Comparison Trial (DETECT): A Secondary Analysis of a Randomized Clinical Trial. JAMA Ophthalmol. 2019 Jul 1;137(7):747-754. doi: 10.1001/jamaophthalmol.2019.0877.
Chamberlain W, Lin CC, Austin A, Schubach N, Clover J, McLeod SD, Porco TC, Lietman TM, Rose-Nussbaumer J. Descemet Endothelial Thickness Comparison Trial: A Randomized Trial Comparing Ultrathin Descemet Stripping Automated Endothelial Keratoplasty with Descemet Membrane Endothelial Keratoplasty. Ophthalmology. 2019 Jan;126(1):19-26. doi: 10.1016/j.ophtha.2018.05.019. Epub 2018 Jun 23.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IRB00010818
Identifier Type: -
Identifier Source: org_study_id